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Senior Executive – Pharmacovigilance

2-4 years
Not Disclosed
10 Sept. 5, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Pharmacovigilance Specialist
Department: Pharmacovigilance
Job Category: PSMF / SDEAs
Job Code: PZPV011
Location: Ahmedabad
Vacancy: 1

Qualifications

  • B. Pharm / M. Pharm

  • 2–4 years of relevant experience

Key Responsibilities

  • Authoring of aggregate safety reports:

    • PSURs / PBRERs

    • PADERs / Annual Reports / ACO

    • DSURs for submission to local and global Health Authorities

  • Preparation of Risk Management Plans (RMPs) as part of routine pharmacovigilance activities

  • Authoring of Signal Management Reports

  • Conducting literature searches and performing validity checks for aggregate reports

  • Reconciling and maintaining process trackers

  • Extracting and validating data (e.g., RSI, sales, previous reports, RMP, signals)

  • Generating Line Listings (LL) from the safety database

  • Providing reliable support for high-priority ad-hoc requests

  • Ensuring timely drafting and submission of all reports within allocated deadlines